EXINI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.

Device Description

The EXINI software provides trained health-care professionals and researchers with a software tool set for acceptance, transfer, storage, image display, manipulation and quantification of digital medical images. The software is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT) modalities. The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for markup and analysis of bone lesions in bone scans. The software complies with the Digital Imaging and Communications in Medicine (DICOM 3) standard. The software runs on a standard PC with Microsoft Windows operating system.

AI/ML Overview

The provided 510(k) summary for the EXINI device states that clinical performance data was NOT conducted to support this submission. Therefore, the document does not contain information about a study proving the device meets acceptance criteria based on clinical performance.

The non-clinical performance data section refers to "verification and validation (V&V) plan including definition of test methods and acceptance criteria was designed to ensure equivalent performance with the predicate device." However, specific acceptance criteria and detailed reported performance metrics for the EXINI device regarding its image processing and analysis capabilities are not explicitly provided in the excerpt. Instead, it concludes that the non-clinical performance data shows "equal performance and raises no new questions of safety and effectiveness in comparison to the predicate device."

Without specific acceptance criteria and reported device performance from a clinical study, it's not possible to populate the table or answer most of the requested questions.

Here's a breakdown of what can be extracted and what is explicitly stated as not available:

1. A table of acceptance criteria and the reported device performance

Not available in the provided text for clinical performance. The document states "Clinical testing was not conducted to support this 510(k) submission."
For non-clinical performance, the document vaguely mentions "test methods and acceptance criteria was designed to ensure equivalent performance with the predicate device," but does not provide the specific criteria or reported performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not available. Since no clinical study was conducted, there is no test set for clinical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not available. Since no clinical study was conducted, there's no ground truth established for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not available. Since no clinical study was conducted, there's no adjudication method for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was explicitly NOT done. The document states "Clinical testing was not conducted to support this 510(k) submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone clinical performance study was explicitly NOT done. The document states "Clinical testing was not conducted to support this 510(k) submission." The device is described as "semi-automatic" and requires a "manual step (hotspot verification step) where the user reviews and edits the selection of hotspots." This indicates it's designed for human-in-the-loop operation, and no standalone clinical performance was assessed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not available. Since no clinical study was conducted, there is no ground truth Type established for clinical performance.

8. The sample size for the training set

Not available. The document does not provide information about a training set since it focuses on the predicate device equivalence based on technological characteristics and non-clinical V&V. AI/ML models typically require a training set, but this document does not detail its development beyond stating it uses "image processing techniques for segmentation of skeletal regions, normalization and hotspot contouring/segmentation."

9. How the ground truth for the training set was established

Not available. The document does not provide information about a training set or how its ground truth might have been established.

Summary of available information regarding compliance:

The EXINI device passed non-clinical performance data testing. The "verification and validation (V&V) plan including definition of test methods and acceptance criteria was designed to ensure equivalent performance with the predicate device" (IBIS Explorer and Markup Software). The V&V test results indicated that EXINI "meets its intended use, user needs and software requirements."

The conclusion is that the non-clinical performance data showed "equal performance and raises no new questions of safety and effectiveness in comparison to the predicate device." This means the device was cleared based on demonstrating substantial equivalence to a predicate device through non-clinical testing and shared technological characteristics, not through a clinical study demonstrating specific performance metrics against an established ground truth.

Summary

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510(k) Summary EXINI EXINI Diagnostics

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510(k) Summary

AUG 15 2012

Submitter Information

EXINI Diagnostics ABScheelevägen 19ASE-223 70 LundSweden
Contact Person:	Allison Scott317.569.9500ascott@ansongroup.com
Date:	June 6, 2012
Trade Name:	EXINI
Common Name:	Picture Archiving and Communications System (PACS)
Classification Name(s):	System, Image Processing, Radiological
Classification Number:	21 CFR 892.2050, LLZ

Predicate Device(s)

510(k) Number	Device Name	Submitter Name
K111319	IBIS Explorer and Markup Software------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Canadian Canada College of Children Comments of Children Come ofMEDQIA

Device Description

The software runs on a standard PC with Microsoft Windows operating system.

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510(k) Summary EXINI EXINI Diagnostics

Intended Use(s)

Technological Characteristics

EXINI and the IBIS Explorer and Markup Software have similar technological characteristics in that they are both software devices that provide general PACS functions with DICOM compatibility and image display. Both devices use image processing techniques for segmentation of skeletal regions, normalization and hotspot contouring/segmentation. Both devices are semi-automatic in that they require a manual step (hotspot verification step) where the user reviews and edits the selection of hotspots that are used as input for quantitative analysis. Both devices perform quantitative analysis based on 2D ROI (regions of interests) measurements in wholebody bone scans.

Non-Clinical Performance Data

The verification and validation (V&V) plan including definition of test methods and acceptance criteria was designed to ensure equivalent performance with the predicate device. The verification included software unit testing, integration testing and software system testing with functional testing of all software requirements. The validation process was performed to ensure that the system meets the user needs specification. The V&V test results showed that EXINI meets its intended use, user needs and software requirements.

Clinical Performance Data

Clinical testing was not conducted to support this 510(k) submission.

Non-Clinical and Clinical Performance Data Conclusions

The non-clinical performance data concludes that the subject device has equal performance and raises no new questions of safety and effectiveness in comparison to the predicate device.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

AUG 15 2012

EXINI Diagnostics AB % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K122205

Trade/Device Name: EXINI Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 24, 2012 Received: July 25, 2012

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally is to (1) person is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Tot use stated in the encrosure) to regars) activent date of the Medical Device Amendments, or to commerce province to May 20, 1976, the encordance with the provisions of the Federal Food. Drug, de vices that nave been require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not required to the general controls provisions of the Act. The T ou thay, therefore, thanket the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such II your device is classified (sec above) into enas frecting your device can be found in Title 21, additional controls. Existing major regerances and to 895. In addition, FDA may publish further Sode of recents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination and any of the ot that FDA has made a determination that your device complies with other requirements of the Act that TDA has made a determination administered by other Federal agencies. You must of any Federal statutes and regulations and limited to: registration and listing (21 Comply with an the Fict 5 requirements 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requireneuls as set forut in the quality of come ( < >> ( = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = will anow you to begin marketing your averalence of your device to a legally marketed notification. The FDA imania of successification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific advice of In Vitro Diagnostic Device Eyaluation and Safety at (301) 796809), please contact the Office of In Vitro Diagnostic Device of to remarket 607), please connect the regulation entitled, "Misbranding by reference to premarket 5450. Also, prease note the regulation vialers, "For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDR regulation (21 CFR Pat 003), products good on default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtail other geleral mionmation on Jour Food Food and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: EXINI

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)

Division Sign-Off Devices
Division of Radiological Devices

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).